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Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 18, 2017 - Issue sup1: Edaravone (MCI-186) in Amyotrophic Lateral Sclerosis (ALS). Guest Editor: Angela Genge
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Original Article

Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis

Koji TakeiMitsubishi Tanabe Pharma Development America, Jersey City, NJ, USA and Correspondence[email protected]
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,
Kikumi TsudaMitsubishi Tanabe Pharma Development America, Jersey City, NJ, USA and View further author information
,
Fumihiro TakahashiMitsubishi Tanabe Pharma Corporation, Tokyo, JapanView further author information
&
Joseph PalumboMitsubishi Tanabe Pharma Development America, Jersey City, NJ, USA and ;Mitsubishi Tanabe Pharma Corporation, Tokyo, JapanView further author information
Pages 64-70 | Received 03 May 2017, Accepted 03 Aug 2017, Published online: 05 Sep 2017

References

  • Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, et al. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014;15:610–17.
  • The Edaravone (MCI-186) ALS 16 Study Group. A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18 (Suppl). Epub ahead of print. doi: 10.1080/21678421.2017.1363780.
  • The Writing Group for the Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505–12.
  • The Writing Group for the Edaravone (MCI-186) ALS 19 Study Group. Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18 (Suppl). Epub ahead of print. doi: 10.1080/21678421.2017.1364269.
  • Berry JD, Miller R, Moore DH, Cudkowicz ME, van den Berg LH, Kerr DA, et al. The Combined Assessment of Function and Survival (CAFS): a new endpoint for ALS clinical trials. Amyotroph Lateral Scler Frontotemporal Degener. 2013;14:162–8.
  • Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38:963–74.
  • Takahashi F, Takei K, Tsuda K, Palumbo J. Post-hoc analysis of study MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(Suppl). Epub ahead of print. doi: 10.1080/21678421.2017.1361442.
  • EFNS Task Force on Diagnosis and Management of Amyotrophic Lateral Sclerosis. EFNS guidelines on the clinical management of amyotrophic lateral sclerosis (MALS)–revised report of an EFNS task force. Eur J Neurol. 2012;19:360–75.
  • Simpson EP, Henry YK, Henkel JS, Smith RG, Appel SH. Increased lipid peroxidation in sera of ALS patients: a potential biomarker of disease burden. Neurology. 2004;62:1758–65.

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